Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
This prospective observational cohort study aims to evaluate the role of innate immune immunoparalysis in the development of ventilator-associated pneumonia (VAP) in critically ill mechanically ventilated patients. Immunoparalysis will be assessed through monocyte HLA-DR expression and ex vivo lipopolysaccharide (LPS)-stimulated TNF-α production.
The study will include three cohorts: elderly patients (≥65 years), younger adults (\<65 years), and healthy controls. The primary objective is to determine whether the presence, duration, intensity, and trend of immunoparalysis are associated with the incidence of VAP and other ICU-acquired infections. Secondary objectives include characterization of immunoparalysis dynamics, comparison of measurement methods, and evaluation of clinical outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥18 years
Mechanical ventilation expected >48h
Intubation between 24h pre- and 48h post- ICU admission
Informed consent
Disqualifiers
Known severe immunosuppression, including primary immunodeficiency disorders, advanced HIV infection (AIDS), active hematological malignancy under treatment, recent chemotherapy or immunosuppressive therapy
High dose steroids at immunosuppressive doses
Active autoimmune disease
Pregnancy
Trial population
Critically ill adult patients requiring invasive mechanical ventilation for more than 48 hours and admitted to the Intensive Care Unit will be consecutively screened for inclusion. The study will include two patient cohorts (≥65 years and 18-64 years), as well as a cohort of healthy adult volunteers serving as controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
170 Participants
are grouped into 3 trial groupsGroup A: Elderly Mechanically Ventilated Patients (≥65 years)
Group B: Adult Mechanically Ventilated Patients (<65 years)
Group C: Healthy Non-Intubated Controls
Trial outcomes
Primary outcomes
1
Incidence of ventilator-associated pneumonia (VAP)
Occurrence of ventilator-associated pneumonia in critically ill mechanically ventilated patients, defined according to standard clinical, radiological, and microbiological criteria.
Time frame
Up to 28 days after intubationSecondary outcomes
1
Incidence of ICU-acquired infections
Occurrence of secondary infections acquired during ICU stay, including device-related infections and other nosocomial infections diagnosed according to standard clinical, microbiological, and radiological criteria.
Time frame
Up to 28 days after intubation2
Duration of invasive mechanical ventilation
Total number of days under invasive mechanical ventilation during ICU stay.
Time frame
Up to 28 Days after intubation3
All-cause mortality at 28 days
Death from any cause within 28 days after ICU admission.
Time frame
28 days after intubation4
Evolution of Sequential Organ Failure Assessment (SOFA) score
Change in SOFA score over time during ICU stay as a measure of organ dysfunction trajectory.
Time frame
From ICU admission to day 15 or ICU discharge, whichever occurs first.Sponsors and contacts
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Source ClinicalTrials.gov